EPIEN Medical, Inc.

Regulatory Information

HybenX® is approved as a Class I medical device in the European Union and Canada. The HybenX® formulation called ORALMEDIC® is already being sold to consumers in Europe, Canada and the Middle East as a Medical Device Class I and has been since 2005. EPIEN Medical manufactures ORALMEDIC® and recently completed a one year clinical study at the Eastman Dental Institute, University College London.